Study on the Effects of Etrasimod Arginine for Patients with Moderate to Severe Crohn’s Disease

4 1

What is this study about?

This clinical trial is focused on studying Crohn’s Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study is testing a medication called Etrasimod Arginine, which is taken as a tablet. The purpose of the study is to evaluate the safety and effectiveness of this medication as a treatment for people with moderately to severely active Crohn’s Disease.

Participants in the study will be randomly assigned to receive either the Etrasimod Arginine tablet or a placebo. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, with regular check-ins to monitor the participants’ health and the effects of the treatment.

The study aims to determine the best dose of Etrasimod Arginine for treating Crohn’s Disease by comparing the effects of two different doses. Researchers will look at how well the medication works in reducing the symptoms of the disease and how safe it is for the participants. The ultimate goal is to find a dose that is both effective and safe for long-term use in managing Crohn’s Disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of Crohn’s disease, and previous treatment history.

Written informed consent is required, and the ability to comply with the study schedule is assessed.

2 induction therapy

The induction phase involves taking etrasimod arginine tablets orally. The dosage and frequency are determined by the study protocol.

This phase aims to evaluate the initial response to the medication over a specified period, typically up to 14 weeks.

3 assessment of response

During the induction phase, the response to treatment is assessed through clinical evaluations and endoscopic examinations.

The primary goal is to observe any endoscopic response and clinical remission, which are key indicators of the medication’s effectiveness.

4 maintenance therapy

If the induction therapy is successful, the patient may continue to the maintenance phase, which involves ongoing administration of etrasimod arginine tablets.

This phase is designed to maintain the therapeutic benefits achieved during induction and is evaluated over a longer period, potentially up to 52 weeks.

5 ongoing monitoring

Throughout the trial, regular monitoring is conducted to ensure safety and track the progress of the treatment.

This includes periodic clinical assessments, laboratory tests, and endoscopic evaluations to monitor the disease activity and any side effects.

6 completion of the trial

Upon completion of the trial, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

The results contribute to the understanding of etrasimod arginine as a potential therapy for Crohn’s disease.

Who Can Join the Study?

  • Participants must be between 18 and 80 years old.
  • Participants must be able to provide written consent and follow the study schedule.
  • Participants must have been diagnosed with Crohn’s Disease for at least 3 months, affecting the ileum (part of the small intestine) and/or colon (part of the large intestine). This diagnosis can be confirmed by past medical tests.
  • Participants must have moderately to severely active Crohn’s Disease, which means a specific score on the Crohn’s Disease Activity Index (CDAI) between 220 and 450, along with certain symptoms like abdominal pain or frequent loose stools, and a specific score on an endoscopic test called SES-CD.
  • Participants must have previously tried and not responded well, lost response, or could not tolerate at least one of the following treatments for Crohn’s Disease: oral corticosteroids, immunosuppressants, TNFα antagonists, integrin receptor antagonists, or interleukin-12/23 antagonists.
  • Females who can become pregnant must not be pregnant.
  • Females who can become pregnant and males must agree to use contraception during the study.

Who Cannot Join the Study?

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an active infection that requires treatment.
  • Patients who have been diagnosed with cancer in the past five years, except for certain types of skin cancer.
  • Patients who have a history of heart problems, such as heart attack or heart failure.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have liver or kidney disease.
  • Patients who have a history of blood clotting disorders.
  • Patients who have a history of mental health disorders that are not well controlled.
  • Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
University Hospital Of Clermont-Ferrand Clermont Ferrand France
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
CHU Grenoble Alpes La Tronche France
Specjalistyczne Gabinety Lekarskie Landa Cracow Poland

Other Sites

Site Name City Country Status
Endomed s.r.o. Kosice Slovakia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Amicare Sp. z o.o. S.K. Lodz Poland
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
PreventaMed s.r.o. Olomouc Czechia
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Algemeen Ziekenhuis Delta Roeselare Belgium
Az Maria Middelares Gent Gent Belgium
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
University General Hospital Of Heraklion Heraklion Greece
Alian s.r.o. Bardejov Slovakia
Solumed Sp. z o.o. sp.k. Poznan Poland
Ip Clinic Sp. z o.o. Lodz Poland
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Poliklinika Borzan d.o.o. Osijek Croatia
Hamburgisches Forschungsinstitut fuer chronisch entzuendliche Darmerkrankungen HaFCED e.K. Hamburg Germany
Termedia Sp. z o.o. Poznan Poland
Dc-Med Michal Kowalski sp.k. Swidnica Poland
Gastro LM s.r.o. Presov Slovakia
KBC Zagreb Zagreb Croatia
Evangelismos S.A. Athens Greece
Bodyclinic Sp. z o.o. sp.k. Warsaw Poland
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Montpellier Montpellier France
Aalborg University Hospital Aalborg Denmark
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Centre Hospitalier Universitaire De Nice Nice France
KM Management spol. s r.o. Nitra Slovakia
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hospital General De Tomelloso Tomelloso Spain
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Universitaetsklinikum Brandenburg an der Havel GmbH Brandenburg An Der Havel Germany
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Agaplesion Frankfurter Diakonie Kliniken gGmbH Frankfurt Germany
Universitaetsklinikum Leipzig AöR Leipzig Germany
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Gastro Jeka s.r.o. Klatovy Czechia
Centrum Zdrowia MDM Warsaw Poland
WIP Warsaw IBD Point Profesor Kierkus Warsaw Poland
Pannonia Maganorvosi Centrum Kft. Budapest Hungary
Htvbmqtf Herguojx Hvidovre Denmark
Uotcilgdreetmknjlmpbr Axnmyahl Augsburg Germany
Tghifiln Spm z osjt Piotrkow Trybunalski Poland
Gdvjwidpgpgpggsys Opnmvodmczi Kassel Germany
Ajhgobtoh Ueo Amsterdam The Netherlands
Argsrny Orkzjblrbvy Ptr Lrwrxjkydqezpznaq Cuzfwalouo Catania Italy
Cqlg Dh Nkyza Vandoeuvre Les Nancy France
Ubrkccrksh Mmwlk Grmaspi Ot Cgqhdkgtb Catanzaro Italy
Facyvlvpd Pdnd Lj Ieczvjiskzbeu Bebxmlcbs Dmw Hyietrxe Uuzxqfufrsdrc Lc Pzo Madrid Spain
Isunepqw dv Csfarrsmmxyt Hrmqpeqztiw Unkanecgndwmp db Sheil Emkkqjc (kszflxk Saint Priest En Jarez France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
14.07.2021
Belgium Belgium
Not recruiting
14.07.2021
Bulgaria Bulgaria
Not recruiting
14.07.2021
Croatia Croatia
Not recruiting
14.07.2021
Czechia Czechia
Not recruiting
14.07.2021
Denmark Denmark
Not recruiting
14.07.2021
France France
Not recruiting
14.07.2021
Germany Germany
Not recruiting
14.07.2021
Greece Greece
Not recruiting
14.07.2021
Hungary Hungary
Not recruiting
14.07.2021
Italy Italy
Not recruiting
14.07.2021
Poland Poland
Not recruiting
14.07.2021
Slovakia Slovakia
Not recruiting
14.07.2021
Spain Spain
Not recruiting
14.07.2021
The Netherlands The Netherlands
Not recruiting
14.07.2021

Trial locations

Investigated drugs:

Etrasimod is an oral medication being studied for its potential to help people with moderately to severely active Crohn’s disease. The trial aims to evaluate how safe and effective etrasimod is when used as an initial treatment. The study also seeks to understand how different doses of etrasimod work in comparison to each other. The goal is to find the most effective and safe dose for further development.

Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The exact cause of Crohn’s Disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The progression of the disease can vary greatly among individuals, with some experiencing mild symptoms and others facing more severe challenges.

Trial ID:
2024-513569-38-00
Protocol code:
C5041006
Trial Phase:
Therapeutic use (Phase IV)

Other Trials to Consider

  • A Phase 3b Study of Guselkumab Compared with Risankizumab in Adults with Moderately to Severely Active Crohn’s Disease

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +7
  • One-Year Effectiveness Study of Guselkumab in Adults with Crohn’s Disease

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France